Study Delivery Lead

Site Name: UK - Hertfordshire - Stevenage Posted Date: Jan 5 2023 Study Delivery Lead – Value, Evidence and Outcomes Are you a clinical operations professional looking for an exciting and varied role in a dynamic, high performing department? Are you currently in a scientific role but looking for a new challenge? This could be the job for you! We are currently looking for a Study Delivery Lead to join our Value, Evidence and Outcomes team. In Value, Evidence and Outcomes (VEO), we lead a wide variety of studies to support the development and reimbursement of GSK’s innovative medicine portfolio. The VEO family is made up of Value Evidence scientists, epidemiologists, patient centred outcomes scientists, patient focussed development leads, data analysts and modellers, as well as critical support functions of study delivery, project management, quality, and business operations who work together to deliver an expanding portfolio. This Study Delivery Lead role within VEO Study Delivery and Quality Operations involves the end-to-end design, execution, and reporting of clinical studies. In this role you will be accountable for: Planning and leading the delivery of VEO studies to timelines, quality, budget, company standards and scientific requirements; from concept protocol to final study report Accountable for coordination and delivery of a fully feasible Study Protocol, Informed Consent Forms, operationally robust study documents and Clinical Study Reports Accountable for the study delivery strategy (e.g. country selection, diversity, patient identification and engagement strategy, recruitment plan, digital platforms/tools etc) With the majority of VEO studies fully outsourced this role includes responsibility and/or accountability to drive assessment, selection, engagement, and management of appropriate vendors Ensure compliance with ICH/GCP & ENCePP guidelines and/or applicable guidelines for VEO studies such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies Make decisions which balance risk/benefit with clear understanding of impact on the study and project; acts to mitigate risk where appropriate Work with matrix partners, Study Delivery Therapy Area Lead and/or manager to develop and manage study level budget within project budget allocation Requires active partnership building for their portfolios and collaboration with therapy aligned staff in other functions. Interact effectively across boundaries with other global functions using influencing and relationship-building skills The types of studies run by VEO include: Interventional studies Non-interventional studies using primary data collection, including prospective studies enrolling patients and or/HCPs, de novo registries, discrete choice experiments, creation of new datasets with secondary data (e.g., with EMRs/chart abstraction), patient reported outcomes development and validation Non-interventional comparative and descriptive studies using secondary data sources, including retrospective studies, burden of illness and drug utilisation studies, prevalence/incidence studies of exposure, risk factors and outcomes Studies utilizing a mixture of existing medical data and the collection of new data via sites or directly via patients Economic modelling studies and supplemental analyses of clinical trials/meta-analyses The position will include: Leadership of a study team with single point accountability for delivery of the study Have primary responsibility and be the point of contact for interactions with Value Evidence Leaders/Scientists, Epidemiologists, Medicines leaders (e.g. MDLs, PPLs, GMALS), and other key stakeholder groups including data management, analytics, legal, compliance and project management Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. *LI-GSK Why you? Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree in life sciences or related discipline Broad understanding of the pharmaceutical industry and the clinical development process Ability to establish and build internal and external relationships at all levels in a highly dynamic matrix environment Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary Ability to work independently and proactively and to take on leadership roles on cross-functional study teams Excellent leadership skills Excellent influencing and negotiation skills Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus: In depth knowledge of study management and knowledge of essential regulatory guidelines worldwide Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience Demonstrated experience leading in a matrix environment to deliver projects, develop clinical plans, and manage change Experience in managing relationships with vendors to ensure successful delivery of projects Why GSK? Uniting science, technology and talent to get ahead of disease together GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more: Annual Report 2021 We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated. In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention. Find out more: Our approach to R&D During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. 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